N/A
N=102
Shared Decision Making in Dialysis
End Stage Renal Disease · Chronic Kidney Diseases
Bottom Line
View on ClinicalTrials.gov: NCT04392440 ↗Enrolled (actual)
102
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Mean Feasibility of Intervention Measure — 16.4; 16.1; 19.0 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- DIAL-SDM (Behavioral); usual care (Other)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Feasibility of Intervention Measure |
16.4; 16.1; 19.0 | — |
| PRIMARY Mean Acceptability of Intervention Measure |
12.7; 12.7; 18.3 | — |
| PRIMARY Mean Total Fidelity of Intervention Measure |
88.1 | — |
Summary
Older patients ≥65 years with chronic kidney disease (CKD) face challenges in decision making about dialysis. These patients report little effort by physicians to elicit treatment preferences, discuss prognoses, or explain the burdens/benefits of dialysis options including conservative management. Older patients with CKD often prefer maintaining the quality of life over prolonging life, and many regret their decision to start dialysis: nearly one quarter withdraw from dialysis each year. Shared dialysis decision-making requires active engagement between nephrologists and patients to align patient, caregiver, and physician communication around common goals. The proposed study is a pilot randomized cluster trial of a dialysis shared decision-making (DIAL-SDM) intervention for nephrologists (n=20) and their patients ≥65 years old (n=60) with an estimated glomerular filtration rate (eGFR) of ≤ 20 ml/min/ /1.73 m2. Nephrologists in the Intervention Group will receive 3 communication training sessions, delivered by a standardized patient instructor (SPI) who enact clinical scenarios and offer feedback. In parallel, patients (and caregivers, if available) will receive 2 coaching sessions provided by health coaches, who will explore each patient's relevant contextual information (values, preferences, and goals), and help them identify and practice important questions for their nephrologist. Nephrologists in the Control Group will provide their patients with usual care. The study outcomes will be assessed during two nephrology office visits and at 6 months.
Eligibility Criteria
Inclusion Criteria
For nephrologist:
- Member of Strong nephrology group working at Strong Memorial Hospital
- Treat patients with CKD
For patients:
- Age ≥65 years old
- Presence of advanced CKD stage 4 or 5 (i.e. e GFR ≤ 20 ml/min)
- Patient's nephrologist is enrolled in the study, and has seen that nephrologist at least once
- Speaks English
- Have not attended a dialysis education class or met with the dialysis education coordinator.
- Have not made a dialysis decision
For Caregivers:
- Self-identified caregiver (per definition: "family member, partner, friend or someone else who is involved with your health care issues, for example, someone who you talk to about personal issues including medical decisions or who comes to doctor appointments with you. This person may also help with routine day-to-day activities, like transportation or paperwork.")
- 21 years of age or older.
Exclusion Criteria
For Nephrologists:
- Expecting to leave in six months.
For Patients:
- Patient has already been seen by a palliative care clinician or is enrolled in hospice
- Is already on dialysis
- Hospitalized at the time of recruitment
- Cognitive impairment
- Does not speak English
For Caregivers:
- If Support is offered primarily in a professional role (e.g., clergy).
- Cognitive impairment
Data sourced from ClinicalTrials.gov (NCT04392440). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.